RU2629550C2 - Changed optical ophthalmological device containing liquid crystalline elements - Google Patents

Abstract

FIELD: physics.

SUBSTANCE: device of an ophthalmological lens with a variable optical insert contains an insert sealing layer containing an optical and a non-optical zone; a variable optical insert, at least, a part of which is located within the optical zone and comprises a layer of liquid crystal material; a power source integrated in the sealing insert and, at least, the first layer of the dielectric material in the immediate vicinity of the layer of the liquid crystal material that varies in thickness in the region of the optical zone.

EFFECT: ability to control the refractive characteristics of the lens by changing the electric field due to the varying thickness of the dielectric layer.

35 cl, 9 dwg

Description

RELATED APPLICATIONS

This application claims the priority of Provisional Application for US Patent No. 61 / 579,695, filed December 23, 2011, the contents of which are the basis of this application and are included in this application.

FIELD OF THE INVENTION

The present invention describes an ophthalmic lens device with the ability to change optical properties, and more specifically, in some embodiments, the manufacture of an ophthalmic lens with a variable optical insert using liquid crystal elements.

BACKGROUND OF THE INVENTION

Traditionally, an ophthalmic lens, such as a contact or intraocular lens, has predetermined optical characteristics. A contact lens, for example, may provide one of the following options: vision correction; cosmetic correction and therapeutic effect, but only a certain set of vision correction functions. Each function is provided by a specific physical characteristic of the lens. Essentially, the design of the lens using light-reflecting properties allows you to adjust the characteristics of vision. The pigment introduced into the lens allows for cosmetic correction. The active agent introduced into the lens provides a therapeutic function.

To date, the optical characteristics of an ophthalmic lens are due to its physical characteristics. Typically, the optical properties are determined and then attached to their lens during the manufacturing process, for example, by casting or turning. After the lens is made, its optical characteristics remain constant. However, users may find it useful to periodically have more than one available optical power to provide accommodation. Unlike those who use glasses and can change glasses to change optical correction, those who wear contact or intraocular lenses still have not been able to change the optical characteristics without such efforts with such methods of vision correction.

SUMMARY OF THE INVENTION

Accordingly, the present invention contains innovations related to a variable optical insert using liquid crystal elements, which can be energized and incorporated into an ophthalmic device and configured to change the optical properties of the lens. Examples of such ophthalmic devices may include, for example, a contact lens or an intraocular lens. In addition, methods and devices for manufacturing an ophthalmic lens with a variable optical insert with liquid crystal elements are presented. A number of embodiments of the invention also includes a molded silicone hydrogel contact lens with a rigid or deformable energized insert that further includes a variable optical portion, the insert being incorporated in an ophthalmic lens in a biocompatible manner.

Thus, the present invention includes a description of an ophthalmic lens with a variable optical insert, a device for manufacturing an ophthalmic lens with a variable optical insert, as well as methods for their manufacture. The energy source can be placed on a variable optical insert, and the insert can be placed close to one or both parts of the mold: the first part of the mold and the second part of the mold. A reactive monomer mixture is placed between the first part of the mold and the second part of the mold. The first part of the mold is placed in close proximity to the second part of the mold, thereby forming a cavity of the lens with an energized insert and at least some reaction monomer in the lens cavity; the reactive monomer mixture is exposed to actinic radiation to form ophthalmic lenses. Lenses are formed by controlling the actinic radiation to which the reactive monomer mixture is exposed. In some embodiments, the edge of the ophthalmic lens or the hermetically sealed insert layer may be formed from standard hydrogel formulations for the ophthalmic lens. Examples of materials with characteristics that provide an acceptable combination with a variety of insert materials include, for example, without limitation, materials of the narafilcon family (including narafilcon A and narafilcon B) and the ethafilcon family (including ethafilcon A).

Methods of manufacturing a variable optical insert with liquid crystal elements and the resulting insert are an important aspect of various embodiments. In a number of embodiments, the liquid crystal is placed between the alignment layers, which can set the rest orientation of the liquid crystal. The two said orienting layers are electrically connected to the energy source by electrodes placed on the layers of the substrate, which contains a variable optical part. The electrodes are energized via an intermediate connection to the energy source or directly through components built into the insert.

Excitation of the energy of the orienting layers causes a liquid crystal to shift from the rest orientation to the energized orientation. In embodiments using two levels of energy excitation, energized and non-energized, the liquid crystal has only one energized orientation. In other alternative embodiments, where the excitation of energy occurs on a scale of energy levels, the liquid crystal may have many energized orientations.

The resulting alignment and orientation of the molecules affects the light passing through the liquid crystal layer, thus causing a change in the variable optical insert. For example, the refractive properties obtained by alignment and orientation affect the incident light. Moreover, such an effect has the effect of disturbing the polarization of light. In some embodiments, a variable optical insert changes the focal characteristics of the lens.

In a number of embodiments, a dielectric substance is disposed between the alignment layer and the electrode. Such embodiments include dielectric material with bulk properties, such as, for example, a preformed shape. Other embodiments include a second dielectric layer, the thickness of the first dielectric layer having different thicknesses in the optical zone, whereby a varying electric field is generated in the liquid crystal layer. In alternative embodiments, the ophthalmic lens device includes a first layer of dielectric substance, which is a mixture of two substances with similar optical properties and different low-frequency dielectric properties.

DESCRIPTION OF DRAWINGS

In FIG. 1 illustrates an example of components of a mold assembly assembly device that can be used to implement some embodiments of the present invention.

In FIG. 2 shows an exemplary embodiment of an energy-powered ophthalmic lens device with a variable optical insert.

In FIG. 3 is a cross-sectional view of an embodiment of an artificial lens with a variable optical insert in which the variable optical part consists of a liquid crystal.

In FIG. 4 is a cross-sectional view of an embodiment of an ophthalmic lens with a variable optical insert in which the variable optical part consists of a liquid crystal.

In FIG. 5 shows an embodiment of a variable optical insert in which the variable optical part consists of a liquid crystal.

In FIG. Figure 6 shows an alternative embodiment of a variable optical insert in which the variable optical part consists of a liquid crystal.

In FIG. 7 shows the steps of a method for manufacturing an ophthalmic lens with a variable optical insert consisting of a liquid crystal.

In FIG. Figure 8 shows an example of components of a device for placing a variable optical insert from a liquid crystal into a part of an mold for casting an ophthalmic lens.

In FIG. 9 shows a processor used to implement some embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes methods and apparatus for manufacturing an ophthalmic lens with a variable optical insert, in which the variable optical part consists of a liquid crystal. In addition, the present invention includes an ophthalmic lens with a variable optical insert, consisting of a liquid crystal embedded in an ophthalmic lens.

According to the present invention, an ophthalmic lens is formed with an integrated insert and an energy source, such as an electrochemical cell or battery, as an energy storage means. In some embodiments, the materials containing the energy source are hermetically sealed and isolated from the environment in which the ophthalmic lens is placed.

To change the optical part, a user-controlled control device is used. The control device includes, for example, an electronic or passive device for increasing or decreasing the output voltage. Some embodiments also include an automated control device for changing a variable optical part with an automated device in accordance with a measured parameter or data entered by a user. Data can be entered by the user, for example, using a switch controlled by a wireless device. A wireless device may include, for example, radio frequency control, magnetic switching, as well as inductive switching.

In some embodiments, the insert also includes a variable optical portion consisting of layers of liquid crystal. A change in the optical power occurs when the electric fields created by the energy supply to the electrodes cause a reorientation inside the liquid crystal layer, thus shifting the molecules from the rest orientation to the energized orientation. In other alternative embodiments, the implementation uses other effects caused by the change in the layers of the liquid crystal as a result of the supply of energy to the electrodes, for example, rotation of the polarization angles.

In some embodiments of the invention with liquid crystal layers in the non-optical zone of the ophthalmic lens, energized are present, while other embodiments of the invention do not require energization. In the above-mentioned variants that do not require excitation by energy, the liquid crystal changes passively as a result of the influence of some external factor, such as, for example, ambient temperature or ambient lighting.

The liquid crystal lens provides an electrically variable refractive index of polarized light incident on the lens body. The combination of two lenses, in which the axis of polarization of the second lens rotates relative to the first lens, allows you to get a lens that is able to change the refractive index of unpolarized ambient light.

The combination of electrically active layers of a liquid crystal with electrodes forms a physical object controlled by the application of an electric field to the electrodes. If a dielectric layer is present in the peripheral zone of the liquid crystal layer, then the field of the dielectric layer and the field of the liquid crystal layer are combined in the field of electrodes. The nature of the three-dimensional form of combining the fields of the layers is estimated based on the principles of electrodynamics of the geometry of the dielectric layer and the liquid crystal layer. If the effective electric thickness of the dielectric layer is heterogeneous, then the effect of the field on the electrodes can have a “shape” of the effective shape of the dielectric and can create dimensional changes in the refractive index in liquid crystal layers. In a number of embodiments, such shaping leads to the formation of lenses capable of acquiring variable focal properties.

The following sections will describe in detail the embodiments of the present invention. Descriptions of both preferred and alternative embodiments of the invention are only examples of the invention. It is assumed that the person skilled in the art will understand the possibilities of creating modifications and other embodiments of the invention. Therefore, it should be borne in mind that the area covered by the present invention is not limited to the given embodiments of the invention.

DEFINITIONS

In the above description and claims relating to the present invention, a number of terms are used for which the following definitions will be adopted:

Orientation layer: in the framework of the present invention relates to a layer located in close proximity to the liquid crystal layer, acting and aligning the orientation of the molecules inside the liquid crystal layer. The resulting alignment and orientation of the molecules affects the light passing through the liquid crystal layer. For example, the refractive properties obtained by alignment and orientation affect the incident light. Moreover, such an effect has the effect of disturbing the polarization of light.

Electrical interaction: in the framework of the present invention relates to a state under the influence of an electric field. In the case of the use of conductive materials, the effect occurs as a result of the flow of electric current or leads to the flow of electric current. When using other materials, an impact, such as, for example, a tendency to orient constant and induced dipole molecules along field lines, for example, causes a field of electric potential.

Energy-powered: within the scope of this document refers to the state in which a device can supply electric current or accumulate electric energy.

Energy-Fueled Orientation: Within the scope of the present invention, it relates to the orientation of liquid crystal molecules when exposed to a potential field connected to an energy source. For example, a device containing liquid crystals has one energy-energized orientation if the source only operates on. and off In other embodiments, the energized orientation varies on a scale depending on the amount of energy transferred.

Energy: This document refers to the ability of a physical system to do work. In the framework of the present invention, the said ability, as a rule, may relate to the ability to perform electrical actions when performing work.

Energy source: as used herein, means a device configured to supply energy or bring a biomedical device into an energized state.

Electricity harvesting device: refers herein to a device capable of extracting energy from the environment and converting it into electrical energy.

Artificial lens: in the framework of the present invention relates to an ophthalmic lens embedded in the eye.

Lens-forming mixture, or reactive mixture, or reactive monomer mixture (PCM) - as used herein, the term refers to a monomer or prepolymer material that can be polymerized and cross-linked or cross-linked to form an ophthalmic lens. Various embodiments include lens-forming mixtures with one or more additives, such as: UV blockers, dyes, photoinitiators or catalysts, and other additives that may be needed as part of ophthalmic lenses, such as, for example, contact or intraocular lenses.

Lens-forming surface: herein refers to the surface used to cast the lens. In some embodiments, any such surface is a surface of optical cleanliness and quality, which means that the surface is sufficiently smooth and made in such a way that the surface of the lens formed by polymerization of the lens-forming mixture in direct contact with the surface of the mold optically acceptable quality. In addition, in some embodiments, the lens-forming surface may have the geometry necessary to impart the desired optical characteristics to the lens surface, including, for example, spherical, aspherical, and cylindrical forces, correction of wavefront aberrations, and correction of corneal topography.

Liquid crystal: as used herein, the term refers to the state of a substance possessing the properties of a standard liquid and a solid crystal. A liquid crystal cannot be considered as a solid, but its molecules show a certain degree of organization. As used herein, the term “liquid crystal” is not limited to a particular phase or structure, but such a liquid crystal may have a specific orientation at rest. The orientation and phases of the liquid crystal can be changed by external influences, such as, for example, temperature, magnetic or electric field, depending on the class of liquid crystal.

Lithium-ion cell: as used herein, means an electrochemical cell in which electrical energy is generated by the movement of lithium ions through a cell. This electrochemical cell, usually called a battery, in its typical form can be returned to a state with a higher charge or recharged.

Substrate insert or insert: as used herein, means a moldable or rigid substrate that maintains an energy source in an ophthalmic lens. In a number of embodiments, the substrate insert also includes one or more variable optical parts.

Injection mold: herein refers to a rigid or semi-rigid object that can be used to form lenses from uncured formulations. Some preferred molds include two parts forming a front curved part of the mold and a back curved part of the mold.

Ophthalmic lens, or lens: as used herein, the term refers to any ophthalmic device located in or on the eye. Such devices may provide the possibility of optical or cosmetic correction. For example, the term “lens” refers to a contact lens, intraocular lens, patch lens, ocular insertion, optical insertion, or other device of a similar purpose, used to correct or modify vision or cosmetic correction of the physiology of the eye (for example, changing the color of the iris) without prejudice for sight. In some embodiments, preferred lenses of the present invention are soft contact lenses made of silicone elastomers or hydrogels, which include, for example, silicone hydrogels and fluorine hydrogels.

Optical zone: herein refers to the area of the ophthalmic lens through which the user of the ophthalmic lens looks.

Power: as used herein, means perfect work or energy transferred per unit of time.

Rechargeable or rechargeable: in this document means the ability to be recharged or transferred to a state with a higher ability to perform work. Many applications within the framework of the present invention may relate to the ability to restore the specified ability, in which an electric current of a certain magnitude is emitted for a certain period of time.

Recharge or recharge: in the framework of the present invention relates to the return of the energy source to a state with a greater ability to perform work. In the framework of the present invention, the said ability, as a rule, may relate to restoring the ability of the device to emit an electric current of a certain magnitude over a certain period of time.

Released from the mold: in the framework of the present invention relates to a lens that is either completely separated from the mold, or only loosely attached to it so that it can be separated by light shaking or sliding with a tampon.

Rest orientation: in the framework of the present invention relates to the orientation of the molecules of the liquid crystal device at rest, that is, an energy-free state.

Variable optics: in the framework of the present invention relates to the ability to change optical properties, such as, for example, the optical power of the lens or the angle of polarization.

OPHTHALMIC LENSES

The figure 1 presents the device 100 for the formation of ophthalmic devices containing sealed inserts. The device includes an example of a mold for casting the front curved surface 102 and a corresponding mold for casting the rear curved surface 101. The variable optical insert 104 and the body 103 of the ophthalmic device can be placed inside the casting mold for the front curved surface 102 and the casting mold for the back curved surface 101 In a number of embodiments, the material of the body 103 is a hydrogel material, and the variable optical insert 104 is surrounded by this material on all surfaces.

The variable optical insert 104 comprises a plurality of liquid crystal layers 109 and 110. Other options include a single liquid crystal layer; Some of these options are described in the following sections. When using the device 100, you can create a new ophthalmic device, formed from a combination of components with many sealed areas.

In a number of embodiments, the lens with a variable optical insert 104 includes a rigid central part with soft edges, in which the central hard optical element containing the liquid crystal layers 109 and 110 is in direct contact with the atmosphere and corneal surface of the anterior and posterior surfaces, respectively. The soft edges of the lens material (typically a hydrogel-based material) are attached around the periphery of the rigid optical element, which also adds energy and functionality to the resulting ophthalmic lens.

2 is a top-down view of an exemplary embodiment of a variable optical insert 200. In this image, a power source 210 is shown in the peripheral part 211 of a variable optical insert 200. The energy source 210 includes, for example, a thin film, a rechargeable lithium-ion battery, or an alkaline battery batteries. Energy source 210 may be connected to contact points 214 to provide interconnection. The wires may be a wire connection; the wire connection can connect the contact points 214 with the energy source 210 and the photocell 215, which can be used to replenish the energy source 210. Additional wires connect the energy source 210 to the circuit of any interconnecting structure with a soldered wire contact. In other embodiments, the insert has interconnect elements located on its surface.

In some embodiments, the variable optical insert 200 includes a flexible substrate. This flexible substrate may have a shape close to the typical shape of the lens, similar to that described above. However, to provide additional flexibility, the variable optical insert 200 may have additional shape features, such as radial longitudinal cuts. Various electronic components 212 may also be included, such as integrated circuits, discrete components, passive components, and other similar devices.

The variable optical part 213 is also shown in the illustrations. The optical part can be changed at the command of an electric current passing through the variable optical part. In some embodiments, the variable optical portion 213 consists of a liquid crystal thin film located between two layers of a transparent substrate.

Variable optical insert containing liquid crystal elements

Figure 3 shows an intraocular lens 300 with a configuration comprising flat liquid crystal layers in combination with formed dielectrics and transparent electrodes. In a number of embodiments, the intraocular lens 300 includes a first liquid crystal layer 335 located between two optically transparent substrate layers 305 and 345. The liquid crystal layer 335 may also be located between two transparent electrodes 310 and 345, which are in electrical connection with the energy source. A transparent electrode 310 is mounted on this substrate. In a number of embodiments, the electrode 310 consists of a transparent conductive oxide, such as, for example, indium and tin oxide (ITO). This electrode 310 is electrically connected to an electronic control element outside the optical zone of the lens.

The figure 3 shows the first element of the lens 315, consisting of a single dielectric material. In a number of embodiments, the second lens element 320 has dielectric properties different from the dielectric properties of the first lens element. In a number of embodiments, the selection of material includes a combination of materials that have different dielectric constants at low frequencies, but which have combined properties in the optical spectrum. The first element of the lens 315 is made of optical glass or plastic, and the second element of the lens 320 includes a water-based solution, which in some embodiments has a combined refractive index with the first element 315 for optical light.

Some embodiments also include a middle substrate layer 325, which includes an orientation layer 330. A second orientation layer 340 is located on the second optically transparent substrate 350. A second orientation layer 340 is located between the liquid crystal 335 and the second electrode 345, which is attached to the second substrate layer 350.

The liquid crystal layer 335 is in electrical connection with the electrodes 310 and 345, while the excitation using an energy source charges the electrodes 310 and 345, which leads to the creation of an electric field in the region between them. An example result of an electric field in the region of a liquid crystal layer is the rotation of molecules in the layer and, as a result, a shift in the polarization properties of the layer. In another example, this shift in the orientation of the molecules in the liquid crystal layer 335 can cause a change in the liquid crystal layer from a rest orientation to an energized orientation. In embodiments where the excitation is switched between two states, activated or inactive, the liquid crystal layer 335 has only a rest orientation and an energized orientation. In other alternative embodiments, where the excitation occurs on a scale of energy levels, the liquid crystal 335 may have a variety of energized orientations.

In some embodiments, the intraocular lens 300 includes a second liquid crystal layer system 390. Said second system 390 may overlap with the first system 380 by including a second substrate layer 350, although the second system 390 still operates independently of the first layer system 380. The second layer system 390 has the same configuration as the first layer system 380 or, in other embodiments, has a different configuration. As in the first layer system 380, the electrodes are bonded to the liquid crystal layer. The system of the second layer 390 operates in the same way as the system of the first layer 380. Alternatively, the liquid crystal layer 335 of the first system 380 is made of a substance other than the liquid crystal layer of the second system 390.

Figure 4 shows an ophthalmic lens 400 with an integrated variable optical insert 410. Insert 410 has a variable optical part 402 with a liquid crystal layer 404. Like the intraocular lens 300 shown in figure 3, insert 410 has a plurality of liquid crystal layers 404 and 405. Parts of insert 410 overlap to the optical zone of an ophthalmic lens 400.

Figure 5 shows a variable optical part 500 that is inserted into an ophthalmic lens, as well as a liquid crystal layer 525. The variable optical part 500 has the same variety of materials and structural correspondence as discussed in other sections of this description. In a number of embodiments, the transparent electrode 550 is placed on the first transparent substrate 555. The first lens element 540 is made of a dielectric film that is placed on the first transparent electrode 550. In such embodiments, the dielectric layer shape of the first element of the lens 540 forms a dielectric shape, such as shown in the figure. In a number of embodiments, for example, the formed layer is formed by injection molding on a combination of the first transparent electrode 550 and the substrate 555.

A liquid crystal layer 525 is disposed between the first transparent electrode 550 and the second transparent electrode 515. A second transparent electrode 515 is connected to the upper layer of the substrate 510, the device formed from the upper layer of the substrate 510 to the lower layer of the substrate 555 contains a variable optical part 500 of an ophthalmic lens. Two orientation layers 530 and 520 surround the liquid crystal layer 525. Said orientation layers 530 and 520 function to determine the resting orientation of the ophthalmic lens. In a number of embodiments, the layers of electrodes 515 and 550 are in electrical connection with the liquid crystal layer 525 and cause a shift in orientation from the resting orientation to at least one energetically energized orientation.

Figure 6 shows an alternative variant of a variable optical part that can be inserted into an ophthalmic lens, as well as a liquid crystal layer 625. By analogy with a variable optical insert 500 shown in figure 5, layering of substrates 635 and 655 and dielectric materials as on the first lens element 645 and on the second element of the lens 640, leads to a three-dimensional shape, which can affect the optical properties of the liquid crystal layer 625. The first transparent electrode 650 is located on the first layer of the substrate 655 variable optical part of 600 ophthalmic lens.

Since each layer 635, 655, 645, and 640 included in the variable optical insert 600 has a three-dimensional property, the nature of the upper layer of the substrate 610 and the lower layer of the substrate 655 may be more complex than similar elements 305 and 350, respectively, in the intraocular lens 300. B In some embodiments, the shape of the upper layer of the substrate 610 may differ from the lower layer of the substrate 655. Some embodiments include a first lens element 645 and a second element of the lens 640, both of which are composed of dielectric material. The second element of the lens 640 has dielectric properties different from the dielectric properties of the first element of the lens 645 at a low frequency, but is comparable to the optical spectrum of the first element of the lens. The materials of the second lens element 640 include, for example, aqueous fluids comparable to the optical properties of the first lens element 645.

The variable optical insert 600 includes a middle layer of the substrate 635, which forms the surface layer on which the liquid crystal layer 625 is located. In some embodiments, the middle layer of the substrate 635 also acts to hold the second lens 640 if said second lens element 640 is in liquid form. Some embodiments include a liquid crystal layer 625 located between the first orientation layer 630 and the second orientation layer 620, the second orientation layer 620 being placed on the second transparent electrode 615. The upper layer of the substrate 610 contains a combination of layers that form a variable optical insert 600, which reacts to electric fields applied to its electrodes 650 and 615. Orientation layers 620 and 630 affect the optical properties of the variable optical insert 600 in various ways, in lyuchaya, for example, those disclosed in Figures 3 and 12.

MATERIALS

Variants of microinjection molding may include, for example, a resin based on a poly (4-methylpent-1-en) copolymer used to make lenses with a diameter of about 6 to 10 mm, a radius of the front surface of about 6 to 10 mm, and a radius of the back surfaces from about 6 to 10 mm; and a center thickness from about 0.050 to 1.0 mm. Some examples of embodiments include an insert with a diameter of approximately 8.9 mm, a radius of the front surface of approximately 7.9 mm, a radius of the rear surface of approximately 7.8 mm, and a thickness of the center of approximately 0.200 mm and an edge profile of approximately 0.050 radius.

An insert with a variable optical part 104 may be placed in the parts of the mold 101 and 102 used for the manufacture of an ophthalmic lens. The material of the parts of the mold 101 and 102 may contain, for example, a polyolefin or one or more of the following materials: polypropylene, polystyrene, polyethylene, polymethyl methacrylate, as well as modified polyolefins. Other molds may be made of ceramic or metal material.

A preferred alicyclic copolymer contains two different alicyclic polymers. Different grades of alicyclic copolymers can have a glass transition temperature from 105 ° C to 160 ° C.

In some embodiments, implementation of the present invention, the form may contain polymers such as polypropylene, polyethylene, polystyrene, polymethyl methacrylate, modified polyolefins with an alicyclic component in the main chain and cyclic polyolefins. A similar mixture can be used to make any half of the mold or both halves at the same time, moreover, this mixture is preferably used to make the rear curved surface, and the front curved surface consists of alicyclic copolymers.

A number of preferred methods for making molds 100 for the purposes of the present invention use injection molding in accordance with known methods, however, acceptable implementations may also include molds made using other methods, including turning, diamond turning, and also laser cutting.

Typically, lenses are formed on at least one surface of both parts of the mold 101 and 102. However, in some embodiments, one surface of the lens can be formed from part of the mold 101 or 102, and the other surface of the lens can be formed by turning or any in other ways.

In some embodiments, a preferred material includes a silicone component. By “silicon-containing component” is meant any component containing at least one [–Si – O–] unit of a monomer, macromer, or prepolymer. The total content of Si and directly bonded O to the silicone-containing component in question is preferably more than about 20 weight percent and more preferably more than 30 weight percent of the total molecular weight of the silicone-containing component. Suitable silicon-containing components for the purposes of the present invention preferably comprise polymerizable functional groups, such as acrylate, methacrylate, acrylamide, methacrylamide, vinyl, N-vinyl lactam, N-vinyl amide and styryl functional groups.

In some embodiments, the edges of the ophthalmic lens, also called the hermetically sealed insert layer that surrounds the insert, can be formed from standard hydrogel compositions for an ophthalmic lens. Examples of materials with characteristics that can provide an acceptable combination with a variety of insert materials can include, but are not limited to, the materials of the narafilcon family (including narafilcon A and narafilcon B) and the ethafilcon family (including ethafilcon A). Below is a more complete, from a technical point of view, description of the nature of the materials that can be used in the field presented in this document. One skilled in the art will understand that other materials than those described below also allow the formation of an acceptable shell or partial shell for sealed inserts and should be considered in accordance with the scope of the claims and within this scope.

Suitable silicon-containing components for the purposes of the present invention include compounds of formula I

Where

the R ¹ fragment is independently selected from the group consisting of monovalent reactive groups, monovalent alkyl groups or monovalent aryl groups, each of the listed chemical groups may further comprise functional groups selected from hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen, as well as various combinations thereof; monovalent siloxane chains comprise 1-100 repeating Si-O blocks and may additionally contain functional groups selected from the following series: alkyl, hydroxy, amino, oxa, carboxy, alkylcarboxy, alkoxy, amido, carbamate, halogen, and their various combinations;

where b = from 0 to 500, and it is understood that if b is nonzero 0, then b has a distribution with a mode equal to the specified value;

wherein at least one R ¹ contains a monovalent reactive group, and in some embodiments, one to 3 R ¹ contains monovalent reactive groups.

As used herein, the term “monovalent reactive groups” refers to groups capable of undergoing free radical and / or cationic polymerization reactions. Representative but non-limiting examples of free radical reactive groups include (meth) acrylates, styryls, vinyls, vinyl esters, C _1-6 alkyl (meth) acrylates, (meth) acrylamides, C _1-6 alkyl (meth) acrylamides , N-vinyl lactams, N-vinyl amides, C _2-12 alkenyls, C _2-12 alkenylphenyls, C _2-12 alkenylnaphthyls, C _2-6 alkenylphenyl-C _1-6 alkyls, O-vinyl carbamates and O-vinyl carbonates. Representative, but non-limiting examples of cationic reactive groups include vinyl ester or epoxy groups, as well as mixtures thereof. In one embodiment, the free radical reactive groups comprise (meth) acrylate, acryloxy, (meth) acrylamide, and mixtures thereof.

Suitable monovalent alkyl and aryl groups for the purposes of the present invention include unsubstituted monovalent C ₁ –C ₁₆ alkyl groups, C ₆ –C ₁₄ aryl groups such as substituted and unsubstituted methyl, ethyl, propyl, butyl, 2-hydroxypropyl, propoxypropyl, polyethyleneoxypropyl, combinations thereof, and the like.

In one embodiment, b is zero, one R ¹ represents a monovalent reactive group and at least 3 R ¹ selected from monovalent alkyl groups having from one to 16 carbon atoms, and in another embodiment, from monovalent alkyl groups, having from one to 6 carbon atoms. Non-limiting examples of silicon-containing components in this embodiment include 2-methyl-, 2-hydroxy-3- [3- [1,3,3,3-tetramethyl-1 - [(trimethylsilyl) oxy] disiloxanyl] propoxy] propyl ether (SiGMA),

2-hydroxy-3-methacryloxypropyloxypropyltris (trimethylsiloxy) silane,

3-methacryloxypropyltris (trimethylsiloxy) silane ("TRIS"),

3-methacryloxypropylbis (trimethylsiloxy) methylsilane and

3-methacryloxypropylpentamethyldisiloxane.

In another embodiment, b is from 2 to 20, from 3 to 15, or in some embodiments, from 3 to 10; at least one terminal fragment of R ¹ represents a monovalent reactive group, and the remaining R ¹ groups are selected from monovalent alkyl groups containing from 1 to 16 carbon atoms, and in another embodiment, from monovalent alkyl groups containing from 1 to 6 carbon atoms. In yet another implementation of the present invention, b is from 3 to 15, one terminal fragment of R ¹ is a monovalent reactive group, the other terminal fragment of R ¹ is a monovalent alkyl group containing from 1 to 6 carbon atoms, and the remaining fragments are R ¹ represents monovalent alkyl groups containing from 1 to 3 carbon atoms. Representative, but not limiting examples of silicone-containing components of such an embodiment of the present invention include (polydimethylsiloxane (MV 400-1000) with a terminal mono (2-hydroxy-3-methacryloxypropyl) propyl ester group) ("OH-mPDMS"), (polydimethylsiloxanes (MV 800-1000) with terminal mono-n-butyl and terminal monomethacryloxypropyl groups), ("mPDMS").

In another embodiment of the present invention, b is in the range from 5 to 400 or from 10 to 300, both end fragments of R ¹ are monovalent reaction groups, and the remaining fragments of R ^{1 are} independently selected from monovalent alkyl groups containing from 1 to 18 carbon atoms which may have ester bridging groups between carbon atoms and may also include halogen atoms.

In one embodiment, when it is necessary to manufacture a silicone hydrogel lens, the lens constituting the subject of the present invention is made from a reaction mixture containing at least about 20 and preferably from about 20 to 70% by weight. silicon-containing components based on the total weight of the components containing the reactive monomer from which the polymer is made.

In another embodiment, from one to four R ¹ contain vinyl carbonate or carbamate of the following formula:

Formula II

in which: Y is O-, S- or NH-;

R is hydrogen or methyl; d is 1, 2, 3 or 4; and q is 0 or 1.

Silicon-containing vinyl carbonate or vinyl carbamate monomers specifically include: 1,3-bis [4- (vinyloxycarbonyloxy) but-1-yl] tetramethyldisiloxane; 3- (vinyloxycarbonylthio) propyl- [tris (trimethylsiloxy) silane]; 3- [tris (trimethylsiloxy) silyl] propylallyl carbamate; 3- [tris (trimethylsiloxy) silyl] propyl vinyl carbamate; trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinyl carbonate, and

If it is necessary to obtain biomedical devices with an elastic modulus of less than 200, only one of the fragments of R ¹ must be a monovalent reactive group, and no more than two of the remaining fragments of R ¹ must be a monovalent siloxane group.

Another class of silicone-containing components includes polyurethane macromers with the following formulas:

Formulas IV-VI

(* D * A * D * G) _a * D * D * E ¹ ;

E (* D * G * D * A) _a * D * G * D * E ¹ or;

E (* D * A * D * G) _a * D * A * D * E ¹

wherein:

D is an alkyl diradical, an alkylcycloalkyl diradical, a cycloalkyl diradical, an aryl diradical or an alkylaryl diradical containing from 6 to 30 carbon atoms,

G is an alkyl diradical, cycloalkyl diradical, alkylcycloalkyl diradical, aryl diradical or alkylaryl diradical containing from 1 to 40 carbon atoms which may have ether, thioether or amine bridging groups in the main chain;

* denotes a urethane or ureido-bridging group;

_a is at least 1;

A denotes a divalent polymer radical with the following formula:

Formula VII

R ¹¹ independently represents an alkyl or fluoro-substituted alkyl group having from 1 to 10 carbon atoms, which may have ether bonds between carbon atoms; y is at least 1; and p provides a molecular weight of the fragment from 400 to 10,000; each of E and E ¹ independently represents a polymerizable unsaturated organic radical represented by the following formula:

Formula VIII

in which R ¹² represents hydrogen or methyl; R ¹³ represents hydrogen, an alkyl radical having from 1 to 6 carbon atoms, or a —CO — Y — R ¹⁵ radical in which Y represents —O—, Y — S— or —NH—; R ¹⁴ represents a bivalent radical having from 1 to 12 carbon atoms; X is —CO— or —OCO—; Z is —O— or —NH—; Ar means an aromatic radical having from 6 to 30 carbon atoms; w is from 0 to 6; x is 0 or 1; y is 0 or 1 and z is 0 or 1.

Preferably, the silicone-containing component is a polyurethane macromer represented by the following formula:

Formula IX

where R ¹⁶ is a diisocyanate diradical after removal of the isocyanate group itself, for example, an isophorondiisocyanate diradical. Another silicone-containing macromer suitable for the purposes of the present invention is a compound of formula X (where x + y is a number in the range from 10 to 30) obtained by the reaction of fluoroether, hydroxyl-terminated polydimethylsiloxane, isophorone diisocyanate and isocyanatoethyl methacrylate.

Formula X

Other silicone-containing components consistent with the objectives of the present invention include macromers containing polysiloxane, polyalkylene ether, diisocyanate, polyfluorocarbon, polyfluoroether and polysaccharide groups; polysiloxanes with a polar fluorinated grafted or side group containing a hydrogen atom attached to a terminal difluoro-substituted carbon atom; hydrophilic siloxanyl methacrylates containing ether and siloxanyl bridge groups, as well as cross-linked monomers containing polyester and polysiloxane groups. Any of the above polysiloxanes can also be used as the silicone-containing component in the present invention.

Processes

The following process steps are provided as examples of processes that can be implemented in accordance with certain aspects of the present invention. It should be understood that the order of presentation of the stages of the method is not limiting, and other sequences can be used to implement the present invention. In addition, not all of the steps are necessary to implement the present invention, and additional steps may be included in various embodiments of the present invention. It will be apparent to one skilled in the art that, in practice, further embodiments are possible, and such methods are also included in the scope of the claims.

Figure 7 shows a block diagram of exemplary steps that can be used to implement the present invention. In step 701, a first substrate layer is formed, and in step 702, a second substrate layer is formed. At 703, an electrode layer may be deposited on a first substrate layer. Precipitation can occur, for example, by vapor deposition or by electroplating. In some embodiments, the first substrate layer may be part of an insert that has portions in both the optical zone and the non-optical zone. The process of depositing a coating on an electrode can simultaneously determine the interaction features in some embodiments.

At step 704, the first substrate layer can be further processed to add an orientation layer to the previously applied electrode coating layer. Orientation layers can be deposited on the top layer of the substrate, and then processed in a standard manner, such as, for example, by friction techniques, to create grooves that are characteristic of standard orientation layers.

At step 705, the second substrate layer may be further processed. The electrode layer can be deposited on the second substrate layer in a similar manner as was done in step 703. Then, in some embodiments, in step 706, a dielectric layer can be deposited on a second substrate layer located on the electrode layer. The dielectric layer can be formed with a variable thickness over its entire surface. For example, a dielectric layer may be formed on a first substrate layer. Alternatively, the preformed dielectric layer may be attached to the electrode surface of the second substrate part.

In step 707, an orientation layer can be formed on the second substrate layer in the same manner as in the processing step in step 704. After step 707, two separate substrate layers, which can form at least a portion of the ophthalmic lens insert, are ready for attachment. At step 708, these two parts will be brought in close proximity to each other, and then the liquid crystal material will be introduced between the parts. At step 709, the two parts can be located next to each other, and then sealed to form a variable optical element with a liquid crystal.

In a number of embodiments, two parts of the type that were formed in step 709 can be created by repeating the steps of the method from 701 to 709, in which the orientation layers are offset from each other to provide a lens that can control the optical power of unpolarized light. In such embodiments, both variable optical layers can be combined into a single optical variable insert. At step 710, the variable optical element can be connected to a power source and intermediate or attached components can be placed on it.

At step 711, the variable optical insert obtained at step 710 can be placed inside a part of the mold. The variable optical insert may or may not contain one or more components. In some preferred embodiments, the variable optical insert is placed mechanically in the mold part. Mechanical installation may include, for example, the use of a robot or other automation means known in the industry as surface mount components used to install components. It is also contemplated within the scope of the present invention to place a variable optical insert into a mold by a human. Accordingly, for the effective placement of a variable optical insert with an energy source in a part of the casting mold, any mechanical or automated placement methods can be used so that the polymerization of the reactive mixture in the mold parts leads to the manufacture of an ophthalmic lens.

In some embodiments, a variable optical insert mounted in a substrate is placed in the molds. An energy source and one or more components are also fixed in the substrate and are electrically connected to a variable optical insert. Components may include, for example, circuits for controlling the power applied to the variable optical insert. Accordingly, in some embodiments, the component comprises a monitoring mechanism that drives a variable optical insert in order to change one or more optical characteristics, for example, change the state of the first optical power to a second optical power.

In some modifications of the invention, the processor, micro- or nanoelectromechanical systems or other components can also be placed in a variable optical insert and be connected to a power source. At step 712, the reactive monomer mixture is introduced into half the mold. At 713, the first part of the mold is placed in close proximity to the second part of the mold to create a cavity for manufacturing the lens with at least a part of the reactive monomer mixture and a variable optical insert in the cavity. As stated above, preferred embodiments include an energy source and one or more components also located in the cavity, connected by electrical communication with a variable optical insert.

At step 714, the reactive monomer mixture is polymerized in the cavity. The polymerization can be carried out, for example, by exposure to photochemically active radiation or heat, or by using both types of exposure. At step 715, the ophthalmic lens is removed from the parts of the casting mold together with a variable optical insert held on or encapsulated in a polymerized material, hermetically containing the insert from which the ophthalmic lens is made.

Although the invention can be used to make hard or soft contact lenses from any known lens material or material suitable for forming such lenses, it is preferred that the lenses of the present invention are soft contact lenses with a water content of about 0 to 90 percent. More preferably, said lenses are made from monomers containing hydroxyl groups, carboxyl groups, or both types of groups, or made from silicon-containing polymers such as siloxanes, hydrogels, silicone hydrogels, and combinations thereof. A material suitable for forming the lenses of the present invention can be made by reacting mixtures of macromers, monomers and their combinations together with additives such as polymerization initiators. Suitable materials include, without limitation, silicone hydrogels made from silicone macromers and hydrophilic monomers.

Device

Figure 8 shows an automatic apparatus 810 with one or more transfer surfaces 811. The components of the mold, each of which is associated with a variable optical insert 814, are held on a pallet 813 and transferred to the movable surfaces of section 811. Embodiments may include, for example, a single interface between an individually placed variable optical insert 814 or a composite interface (not shown) for the simultaneous placement of variable optical inserts 814 in the components of the form for casting, and in some embodiments, implementation, in each part of the mold. Placement may occur by vertical movement 815 of the movable surfaces of section 811.

A further aspect of some embodiments of the present invention includes a device for holding a variable optical insert 814 while forming an ophthalmic lens body around these components. In some embodiments, the variable optical insert 814 and the energy source may be attached to holding points on a lens mold (not shown). The retention points can be fixed with polymerized material of the same type from which the lens body is formed. Other embodiments include a prepolymer layer in that part of the mold on which the variable optical insert 814 and an energy source are attached.

Boxed processors

9 shows a controller 900 that can be used in some embodiments of the present invention. The controller 900 includes a processor 910, which may include one or more processor components connected to a communications device 920. In some embodiments, the controller 900 is used to transfer energy to an energy source placed in an ophthalmic lens.

The controller may include one or more processors connected to a data exchange device configured to transmit energy through a communication channel. A data exchange device can be used to electronically control one or more of the following processes: placing a variable optical insert into an ophthalmic lens or transmitting a command to control a variable optical device.

The communication device 920 can also be used to communicate, for example, with one or more components of a monitoring device or production equipment.

The processor 910 may also communicate with the storage device 930. The storage device 930 may comprise any appropriate storage devices, including combinations of magnetic storage devices (eg, magnetic tape and hard disk drives), optical storage devices and / or semiconductor storage devices devices, such as random access memory (RAM) and read-only memory (ROM).

A program 940 for controlling the processor 910 may be stored in the storage device 930. The processor 910 executes the instructions of the program 940 and thus operates in accordance with the present invention. For example, processor 910 may receive information describing the location of the variable optical insert, the location of the data processing device, and so on. The data storage device 930 may also store ophthalmic data in one or more databases 950, 960. The databases 950 and 960 may include a special monitoring logic to control the energy coming to and from the variable optical lens.

Claims (65)

1. The device is an energized ophthalmic lens with a variable optical insert, containing: a layer sealing an ophthalmic lens insert comprising an optical zone and a non-optical zone; a variable optical insert comprising at least a portion within the optical zone; an energy source integrated into the ophthalmic lens sealing insert of the material, at least in the region containing the non-optical zone; a variable optical insert containing a layer of liquid crystal material; and at least a first layer of dielectric material, in the immediate vicinity of the layer of liquid crystal material, wherein said first layer of dielectric material varies in thickness in the region of the optical zone. 2. The device according to claim 1, in which the energized ophthalmic lens is a contact lens. 3. The device according to claim 2, in which a variable electric field in the layer of liquid crystal material is formed as a result of the fact that the thickness of the first layer of dielectric material varies in the region of the optical zone. 4. The device according to claim 3, in which a variable optical insert changes the focal characteristics of the energized ophthalmic lens. 5. The device according to claim 3, in which the first layer of dielectric material is a mixture of two materials with similar optical characteristics and excellent low-frequency dielectric properties. 6. The device according to claim 2, in which the energy source excites the components inside the energized ophthalmic lens and causes the liquid crystal material layer to change its polarization effect on the light. 7. The device according to claim 3, in which: a layer of liquid crystal material is located at least between two orienting layers; at least two of these orientation layers are located between at least two layers of electrodes; and said at least two electrode layers are electrically connected to an energy source. 8. The device according to claim 7, in which: a layer of liquid crystal material has at least a first excited orientation; and the excitation of the electrode layers displaces the liquid crystal material layer from the rest orientation to at least the first excited orientation. 9. The device according to claim 1, in which the sealing insert layer of the ophthalmic lens contains a material containing silicone. 10. The device according to claim 1, in which the sealing insert layer of the ophthalmic lens contains etafilikon A. 11. The device according to claim 1, additionally containing a processor. 12. The device according to claim 7, further comprising a processor. 13. The device according to claim 7, in which the energy source contains a scale of energy levels; wherein the layer of liquid crystal material contains a plurality of excited orientations, wherein each of the plurality of excited orientations refers to a different one of the scale of energy levels; and the excitation of at least two layers of electrodes, in particular at one energy level from the energy level scale, causes the liquid crystal material layer to shift from the rest orientation to the corresponding one of the many excited orientations. 14. The device according to claim 1, further comprising a user-controlled control device that optionally modifies the variable optical insert, wherein: the variable optical insert comprises a first electrode and a second electrode, wherein the first electrode and the second electrode are transparent; and a layer of liquid crystal material is located between the first electrode and the second electrode. 15. The device according to 14, in which the user-controlled adjusting device is configured to control the optical power of the energized ophthalmic lens. 16. The device according to clause 15, in which the user-controlled control device is automated in accordance with the measured parameter. 17. The device according to clause 15, in which the regulatory device, controlled by the user, is automated in accordance with the data entered by the user. 18. The device according to clause 15, in which the regulatory device, controlled by the user, contains a switch controlled by a wireless device. 19. The device according to p, in which the wireless device communicates via radio frequency transmission. 20. The device according to p, in which the wireless device communicates by magnetic switching. 21. Energized intraocular lens with a variable optical insert, containing: an intraocular lens with an optical zone and a first non-optical zone; an energy source attached to the intraocular lens in the first non-optical zone; a variable optical insert comprising at least a first layer of liquid crystal material; and at least a first layer of dielectric material in the immediate vicinity of the liquid crystal material layer, wherein the first layer of dielectric material is formed in such a way that it has a different thickness in the optical zone. 22. Energized intraocular lens according to item 21, in which: the first layer of dielectric material is a mixture of at least a first material and a second material with similar optical characteristics and various low-frequency dielectric properties. 23. Energized intraocular lens according to item 22, in which: a variable optical insert changes the focal characteristics of the lens. 24. The energized intraocular lens of claim 23, wherein the energy source excites components within said lens and causes the layer of liquid crystal material to change its refractive effect on light. 25. Energized intraocular lens according to paragraph 24, in which: at least a first layer of liquid crystal material is located between at least two layers of electrodes; and at least two electrode layers are electrically connected to an energy source. 26. The energized intraocular lens of claim 25, wherein: at least a first layer of liquid crystal material has at least a first excited orientation; and the excitation of the electrode layers displaces the liquid crystal material layer from the rest orientation to at least the first excited orientation. 27. The energized intraocular lens of claim 25, further comprising a processor. 28. An intraocular lens energized with energy according to paragraph 24, in which the energy source contains a scale of energy levels; the layer of liquid crystal material contains many excited orientations, with each of the many excited orientations refers to a different one of the scale of energy levels; and the excitation of at least two layers of electrodes, in particular, at the same energy level from the energy level scale, causes the liquid crystal material layer to shift from the rest orientation to the corresponding one of the many excited orientations. 29. An energized intraocular lens according to claim 21, further comprising a user-controlled adjusting device that optionally modifies the variable optical insert, wherein: the variable optical insert comprises a first electrode and a second electrode, wherein the first electrode and the second electrode are transparent; and a layer of liquid crystal material is located between the first electrode and the second electrode. 30. The energized intraocular lens of claim 29, wherein the user-controlled adjusting device is configured to control the optical power of the energized intraocular lens. 31. The energized intraocular lens of claim 30, wherein the user-controlled adjusting device is automated in accordance with the measured parameter. 32. The energized intraocular lens of claim 30, wherein the user-controlled adjusting device is automated in accordance with data entered by the user. 33. The energized intraocular lens of claim 30, wherein the user-controlled adjusting device comprises a switch controlled by a wireless device. 34. An energized intraocular lens according to claim 33, wherein the wireless device communicates via radio frequency transmission. 35. An energized intraocular lens according to claim 33, wherein the wireless device communicates via magnetic switching.

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